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Trial to evaluate steady state pharmacokinetic parameters of nevirapine 150mg/m2 and nevirapine 4 or 7 mg/kg after 4 weeks, and efficacy and safety of the dosing when administered for 48 weeks in antiretroviral drug naïve paediatric patients.

A Randomised Open Label Multi-centre Trial to Evaluate the Pharmacokinetic, Efficacy and Safety Parameters of Nevirapine 150mg/m2 and Nevirapine 4 or 7 mg/kg When Administered in Combination With AZT and 3TC for 48 Weeks in Antiretroviral naïve Paediatric Patients.

A randomised open label multi-centre trial to evaluate the pharmacokinetic, efficacy and safety parameters of nevirapine 150mg/m2 and nevirapine 4 or 7mg/kg when administered in combination with ZDV and 3TC for 48 weeks in antiretroviral naive pediatric patients.

Secondary objective: To assess efficacy and safety of nevirapine 150 mg/m2 and nevirapine 4/7mg/kg after 24 and 48 weeks of treatment

Study Hypothesis:

Evaluation of recent pharmacokinetic data has suggested that a dose based on body surface area rather than body weight might be a better therapeutic regimen to achieve steady state plasma concentrations. The goal in this study was to determine if a Nevirapine suspension dose of 150 mg/m2 BID, following a two week lead-in of 150 mg/m2 QD, produces plasma nevirapine steady state concentrations of 4 - 6 ?g/mL in all age groups as was observed in adult safety and efficacy trials.

Comparison(s):

ACTG 245

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

3 Months to 16 Years (Child)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion:

Male or female patients between 3 months and 16 years of age at day 28 of the study.

Evidence of HIV-1 infection

Patients who are antiretroviral drug naive

Plasma viral load detectable

CD4 >=50 cells/cc3

Written informed permission

Active assent given by the patient if the child is capable of understanding the given information

Reasonable probability for completion of the trial

Exclusion:

Any significant disease, other than HIV

Any acute illness within 2 weeks prior to Day 0

Patients requiring the continued use of inhibitors or inducers of P450 metabolic enzymes

Patients requiring systematic treatment with CYP3A4 substrates

Patients with malabsorption, severe chronic diarrhea

Receipt of any cytotoxic therapy for malignancy

Current grade 3 or 4 clinical or laboratory toxicity

Pregnancy or breast-feeding

Females of childbearing potential not using adequate contraception. allergy or known drug hypersensitivity to any of the study drugs intravenous drug abuse, alcohol or substance abuse

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00273975